Package Insert and Label Information: Hydrogen Peroxide

By Supervalu, Inc | Last revised: 1 January 2011

HYDROGEN PEROXIDE — hydrogen peroxide solution
Supervalu, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient
Hydrogen peroxide (stabilized) 3%
Purpose
First aid antiseptic
Oral debriding agent
Use s
• first aid to help prevent the risk of infection in minor cuts, scrapes and burns
• aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
Warnings
For external use only Do not use
• in the eyes or apply over large areas of the body
• longer than 1 week As a doctor before use if you have deep or puncture wounds, animal bites or serious burns
Stop use and ask a doctor if
• the condition persists or gets worse
• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
• swelling, rash, or fever develops
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
First aid antiseptic:
•clean the affected area
•apply a small amount of product on the affected area 1 to 3 times a day
•may be covered with a sterile bandage
•if bandaged, let dry first
Oral Debriding agent: adults and children 2 years of age and over:
• mix with equal amount of water
• swish around in the mouth over the affected area for at least 1 minute and then spit out
• use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
• children under 12 years of age should be supervised in the use of this product
• children under 2 years of age: consult a dentist or doctor
Other information keep tightly closed and at controlled room temperature. Do not shake bottle. Hold away from face when opening.
Inactive ingredient purified water
DISTRIBUTED BY: SUPERVALU, INC.
EDEN PRARIE, MN 55344
CONTACT US AT 1-877-932-7948
www.supervalu-ourownbrands.com
equaline
NDC 41163-871-43
3% USP
hydrogen
peroxide
topical solution USP
• first aid antiseptic
• oral debriding agent
• for treatment of minor cuts and abrasions
• for use as a gargle or rinse
SEALED WITH PRINTED NECKBAND
FOR YOUR PROTECTION
16 FL OZ
(1 PT) 473 mL

image of principal display panel

HYDROGEN PEROXIDE hydrogen peroxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41163-871
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE)	HYDROGEN PEROXIDE	.3 kg in 100 L

Inactive Ingredients
Ingredient Name	Strength
WATER

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:41163-871-43	.473 L in 1 BOTTLE, PLASTIC	None
2	NDC:41163-871-34	.237 L in 1 BOTTLE, PLASTIC	None
3	NDC:41163-871-45	.946 L in 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/14/2005

Labeler — Supervalu, Inc (006961411)

Registrant — Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Operations
Vi -Jon		790752542	manufacture

Revised: 01/2011 Supervalu, Inc